Trial · NCT01589302
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL. | up to 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percentage of patients | NUMBER |
| SECONDARY | Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines | up to 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percentage of patients | NUMBER |
| SECONDARY | Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients | Up to 6 months | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | patients | NUMBER |
| SECONDARY | Percentage of Patients With Overall Survival (OS) | 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percent of patients | NUMBER |
| SECONDARY | 2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765 | 2 years | There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients | percent of patients | NUMBER |
| SECONDARY | Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 2 years post treatment | patients | NUMBER | |
| SECONDARY | Resistance Studies of Ibrutinib | Up to 4 years | percentage of patients | NUMBER | |
| SECONDARY | Decrease in Immune Suppression of CLL Cells | up to 3 months | Data was not collect and analyzed for this outcome measure | ||
| SECONDARY | Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention | Up to 2 years | participants | NUMBER | |
| SECONDARY | Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R) | Up to 2 years | Data was reported for start of treatment only | units on a scale | MEAN |
| SECONDARY | Cognitive-Affective Depressive Symptoms as Measured by the Beck Depression Inventory-2nd Edition (BDI-II) | at 5 months | Data was reported for month 5 from start of treatment | units on a scale | MEAN |
| SECONDARY | Negative Mood Quality of Life Measured by a 37-item Questionnaire | at 5 months | Data was reported for month 5 from start of treatment | units on a scale | MEAN |
| SECONDARY | Mental Health Quality of Life Was Measured by the Mental Component Summary Score of the Medical Outcomes Study | at 5 months | units on a scale | MEAN | |
| SECONDARY | Fatigue Symptom Inventory (FSI) Interference Quality of Life as Measured by a 11-item Total Disruption Index Sub Scale of Fatigue Symptoms Inventory | at 5 months | Data was reported for month 5 from the start of treatment | units on a scale | MEAN |
| SECONDARY | Sleep Through Quality of Life as Measured by a Medical Outcomes Study-Sleep Scale | at 5 months | Data was reported for month 5 from start of treatment | units on a scale | MEAN |
| SECONDARY | Physical Health Quality of Life as Measured by a 12 Item Short-Form Health Survey | up to 5 months | Data was reported for month 5 from start of treatment | units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01589302/outcomes